The Validation Engineer will create and execute validation documentation ensuring compliance with regulatory agencies like HPRA and FDA within the Medical Device and Pharma Sector
Job Summary
The Validation Engineer will create and execute validation documentation ensuring compliance with regulatory agencies like HPRA and FDA within the Medical Device and Pharma Sector.
This role requires liaising with cross-functional teams and external vendors to drive validation initiatives and support the implementation of Company Policies and GMP.
Candidates must possess strong working knowledge of validation principles including EudraLex, ISO13485, ISO14644, GAMP5, and FDA regulations.
Matching Summary
The Validation Engineer will create and execute validation documentation ensuring compliance with regulatory agencies like HPRA and FDA within the Medical Device and Pharma Sector.
Skills & Requirements
Must-have
Regulatory compliance with HPRA FDA directives
Experience in process validation and capability
Knowledge of EudraLex ISO13485 ISO14644 GAMP5
Development of validation plans protocols reports
Risk assessment documents for regulated processes
Nice-to-have
Experience in method validation and process characterization
Knowledge of LEAN 6 sigma tools
Ability to work in cross functional team environment
Strong technical report writing skills
Excellent interpersonal and communication skills
Key Requirements
Degree in Engineering or Science discipline
3 to 5 years' experience in Validation or Quality engineering